Within the last decade, a variety of gene therapies have been envisioned for an ever- widening spectrum of diseases. By "gene therapies" the investigators mean the modification, with therapeutic intent, of human genes within somatic cells. How can physicians and patients, researchers and subjects, institutions and policymakers make informed decisions about the use of the wide variety of emerging gene therapies? The thesis is that gene therapies raise new and nontrivial ethical concerns that cannot be accounted for by the current legal and ethical framework for informed consent. More specifically, the investigators will challenge and test the Belmont Report's distinction between research and treatment as a basis for informed consent policy. This project aims: (1) to produce an interdisciplinary evaluation of informed decision making about gene therapies; and (2) to develop new policies to guide decisions about the presentation and use of these new therapies. To achieve these aims the investigators will study the legal and ethical development of informed consent doctrine for research and therapy over the past half century. They will undertake a comparative social and historical analysis of two disease-treatment pairs: the genetic modification of autologous hematopoietic stem cells, including but not confined to, autologous bone marrow transplantation (ABMT), for the therapy of sickle cell disease (SCD); and the use of various gene therapy vectors, including but not confined to inhaled modified adenovirus, for the pulmonary manifestations of cystic fibrosis (CF). Close examination and comparison of these two cases -- one prospective and one in clinical trials -- will help illuminate the broad social as well as scientific context that must be appreciated by individuals and institutions before sound policies can be devised and informed decisions made. The products of the project will be: (1) legal, ethical, social and historical analyses, published in the scholarly literature; and (2) the formation of new policy for informed decision making about gene therapy, in collaboration with a panel of consultants.